US2015126608A1PendingUtilityA1
Treatment of preadolescent moderate acne vulgaris
Est. expiryMay 25, 2032(~5.8 yrs left)· nominal 20-yr term from priority
Inventors:Lawrence F. EichenfieldZoe Diana DraelosAnne W. LuckyAdelaide A. HerbertJeffrey SugarmanLinda Stein GoldDiane RudisillHong LiuVasant Manna
A61P 17/10A61K 47/20A61K 9/0014A61K 47/32A61K 47/26A61K 31/327A61K 9/06A61K 47/10A61K 31/192
38
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Claims
Abstract
A method of treating preadolescent acne is described. The method can include administering an effective amount of a pharmaceutical composition that includes a fixed combination of adapalene and benzol peroxide to a preadolescent patient in need thereof. The preadolescent patient can be from age 7 to age 11, and the pharmaceutical composition can include from 0.01% to 2% by weight of adapalene and from 0.1% to 5% by weight by weight of benzol peroxide. Also described, is a composition for use in such a method.
Claims
exact text as granted — not AI-modified1 . A method of treating preadolescent acne, the method comprising administering an effective amount of a pharmaceutical composition comprising a fixed combination of adapalene and benzol peroxide to a preadolescent patient in need thereof, wherein the preadolescent patient is from age 7 to age 11, and wherein the pharmaceutical composition comprises from 0.01% to 2% by weight of adapalene and from 0.1% to 5% by weight by weight of benzol peroxide.
2 . The method of claim 1 , wherein the pharmaceutical composition comprises from 0.05% to 0.5% by weight of adapalene.
3 . The method of claim 1 , wherein the pharmaceutical composition comprises from 0.5% to 5% by weight of benzol peroxide.
4 . The method of claim 1 , wherein the pharmaceutical composition comprises from 0.1% to 0.3% by weight of adapalene and 2.5% by weight of benzol peroxide.
5 . The method of claim 1 , wherein the pharmaceutical composition is formulated as a topical gel.
6 . The method of claim 5 , wherein the topical gel consists of the following formulation in which percents of each ingredient are expressed by weight with regard to the total weight of the composition:
Adapalene
0.10%;
Benzoyl peroxide
2.50%;
Copolymer of acrylamide and sodium
4.00%;
acryloyldimethyltaurate in isohexadecane and
polysorbate 80
Sodium docusate
0.05%;
Glycerol
4.00%;
Poloxamer
0.20%;
Propylene glycol
4.00%; and
Purified water
qs 100%.
7 . The method of claim 1 , wherein the pharmaceutical composition is topically administered to the preadolescent patient for a period of 12 weeks.
8 . The method of claim 1 , wherein the method results in a treatment success of at least 49%.
9 . The method of claim 1 , wherein the method results in a reduction in total lesion count of at least 68%.
10 . The method of claim 1 , wherein the method results in a reduction of inflammatory lesion count of at least 63%.
11 . The method of claim 1 , wherein the method results in a reduction of non-inflammatory lesion count of at least 70%.
12 . The method of claim 1 , wherein the method provides improved treatment success when compared with vehicle alone as early as week 4 of treatment.
13 . The method of claim 1 , method results in total inflammatory and non-inflammatory lesions results were significantly superior as early as week 1 when compared with vehicle alone.
14 . A method of treating non-inflammatory acne lesions in a preadolescent patient, the method comprising topically administering to the skin of the preadolescent patient an effective amount of a fixed combination comprising from about 0.1% to about 0.3% by weight adapalene and about 2.5% by weight BPO, wherein the preadolescent patient is from about age 7 to about age 11 and wherein the amount of the fixed combination administered is effective to result in a reduction of non-inflammatory lesion count of at least about 70%.
15 . The method of claim 14 , wherein the fixed combination is formulated as a topical gel.
16 . The method of claim 15 , wherein the topical gel consists of the following formulation in which percents of each ingredient are expressed by weight with regard to the total weight of the composition:
Adapalene
0.10%;
Benzoyl peroxide
2.50%;
Copolymer of acrylamide and sodium
4.00%;
acryloyldimethyltaurate in isohexadecane and
polysorbate 80
Sodium docusate
0.05%;
Glycerol
4.00%;
Poloxamer
0.20%;
Propylene glycol
4.00%; and
Purified water
qs 100%.
17 . The method of claim 14 , wherein the fixed combination is topically administered to the preadolescent patient for a period of about 12 weeks.
18 . The method of claim 14 , wherein the method results in a treatment success of at least about 49%.
19 . The method of claim 14 , wherein the method results in a reduction in total lesion count of at least about 68%.
20 . The method of claim 14 , wherein the method results in a reduction of inflammatory lesion count of at least about 63%.
21 . The method of claim 14 , wherein the method provides improved treatment success when compared with vehicle alone as early as week 4 of treatment.
22 . A pharmaceutical composition comprising a fixed combination of adapalene and benzol peroxide, for its use in a method of treating preadolescent acne which comprises topically administering said pharmaceutical composition to a preadolescent patient in need thereof, wherein the preadolescent patient is from age 7 to age 11, and wherein the pharmaceutical composition comprises from 0.01% to 2% by weight of adapalene and from 0.1% to 5% by weight by weight of benzol peroxide.
23 . The pharmaceutical composition of claim 22 , wherein said composition comprises 0.05% to 0.5% by weight of adapalene.
24 . (canceled)
25 . The method of claim 2 , wherein the pharmaceutical composition comprises from 0.1% to 0.3% by weight of adapalene.
26 . The method of claim 2 , wherein the pharmaceutical composition comprises from 0.1% by weight of adapalene.
27 . The method of claim 3 , wherein the pharmaceutical composition comprises from 2% to 5% by weight of benzol peroxide.
28 . The method of claim 3 , wherein the pharmaceutical composition comprises from 2.5% by weight of benzol peroxide.
29 . The method of claim 4 , wherein the pharmaceutical composition comprises from 0.1% by weight of adapalene and 2.5% by weight of benzol peroxide.
30 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition comprises from 0.5% to 5% by weight of benzol peroxide.
31 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition comprises from 0.1% to 0.3% by weight of adapalene and 2.5% by weight of benzol peroxide.
32 . The pharmaceutical composition of claim 22 , wherein the pharmaceutical composition is formulated as a topical gel.
33 . The pharmaceutical composition of claim 22 , wherein the topical gel consists of the following formulation in which percents of each ingredient are expressed by weight with regard to the total weight of the composition:
Adapalene
0.10%;
Benzoyl peroxide
2.50%;
Copolymer of acrylamide and sodium
4.00%;
acryloyldimethyltaurate in isohexadecane and
polysorbate 80
Sodium docusate
0.05%;
Glycerol
4.00%;
Poloxamer
0.20%;
Propylene glycol
4.00%; and
Purified water
qs 100%.Join the waitlist — get patent alerts
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